GxP Compliant System Manager

1 week ago


Hyderabad, Telangana, India beBeeEcompliancemanager Full time US$ 1,30,000 - US$ 1,85,000
Job Description:

The eCompliance Manager is responsible for ensuring the quality of computerized systems within the organization. This involves providing Quality Assurance oversight and guidance with regard to CSV operating within the framework of regulations, such as GxP and 21CFR11. The eCompliance Manager also provides operational support in approving GxP impacted changes, Periodic Review Reports, deviations, etc.


Key Responsibilities include: Quality oversight of operational activities of GxP systems, such as Changes, Periodic Reviews, Deviations, etc. Provide needed support to meet applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.


This role requires a solid understanding of global regulations and Health Authorities expectations governing computerized systems, CSV, Part 11, etc. Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments is also essential.


The ideal candidate will have a degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent. A minimum of 10-15 years of overall IT experience, including 7 years of relevant experience in the Pharmaceutical Industry and particularly within regulated functions such as IT Quality and Compliance is required.


Skills and Qualifications:
  • 10-15 years of overall IT experience
  • Minimum 7 years of relevant experience in the Pharmaceutical Industry
  • Solid understanding of global regulations and Health Authorities expectations governing computerized systems
  • Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments
  • Good understanding of system application management, its Quality support approach and industry best practices
  • ITIL, ITSM, etc.

  • Sr. Manager, Gxp T&l

    2 weeks ago


    Hyderabad, Telangana, India Novartis Full time

    Summary LI-Hybrid Location Hyderabad India Are you passionate about shaping a culture of continuous learning and operational excellence As the Senior Manager GxP T L you ll lead a dynamic team dedicated to elevating GxP training standards across Novartis Operations This role offers the opportunity to drive impactful change by designing and...


  • Hyderabad, Telangana, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 23,00,000

    Our team seeks a Compliance Manager to oversee the quality and integrity of our GxP systems.Key Responsibilities:Oversight of operational activities related to regulated computerized systemsSupport for compliance with applicable regulations and industry standardsPoint of contact for CSV-related mattersReview and approval of project documents related to GxP...


  • Hyderabad, Telangana, India beBeeGxp Full time ₹ 5,00,000 - ₹ 7,00,000

    Information Security GxP ExpertWe are seeking an accomplished Information Security GxP Specialist to ensure the security and integrity of our IT systems and data.Key Responsibilities:Manage and mitigate IT GxP deviations, ensuring compliance with relevant regulatory frameworks.Develop and implement effective security controls, including risk assessments,...


  • Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionBasic Qualifications:- 5+ years of experience in IT GxP deviation management, IT quality management, IT auditing, or information security.- Hands-on experience with deviation management tools and associated frameworks (e.g., ISO 27001, NIST, COBIT).- Master's degree and 4 to 6 years of information technology, Cybersecurity, Risk Management, or...


  • Hyderabad, Telangana, India beBeeLeadership Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Lead GxP Training and LearningThis leadership position focuses on driving GxP training standards across operations, ensuring compliance and excellence.About the RoleCoach a dynamic team to elevate GxP training quality, implementing processes that meet regulatory expectations and business objectives.Design and standardize training procedures to align with...


  • Hyderabad, Telangana, India beBeeQuality Full time ₹ 18,00,000 - ₹ 2,13,10,000

    Job Overview:We are seeking a Quality Specialist to join our team. This role will be responsible for ensuring the quality of our products and processes.Collect, monitor, and report Key Performance Indicators (KPIs) for management reporting.Assist in Health Authority inspections and internal audits by providing timely information and documentation.Support the...


  • Hyderabad, Telangana, India HCLTech Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Greetings from HCLHiring for "Computer system validation"Experience- 8-20 YearsLocation- Bangalore / Noida / Chennai / Hyderabad / PuneCTC- Can be discussedJD:Computer System Validation ManagerMandatory Skills CSV Manager, Compliance and Assurance services, LIFESCIENCES GXP FDA CSV IQOQPQ, Leading Offshore CSV Team to drive validation deliverables , Stake...


  • Hyderabad, Telangana, India beBeeLeadership Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    About This Opportunity:Novartis Operations seeks an accomplished Senior Manager to lead the Training, Learning team in elevating GxP training standards across the organization.This role presents a chance to drive impactful change by designing scalable processes, ensuring compliance, and fostering a growth mindset.The successful candidate will be at the...

  • eCompliance Manager

    2 weeks ago


    Hyderabad, Telangana, India Sandoz Full time

    Job Description- Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,)- Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects.- Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface...

  • IT Manager

    4 days ago


    Hyderabad, Telangana, India beBeeCybersecurity Full time ₹ 60,00,000 - ₹ 1,20,00,000

    Job Summary:">This role involves managing IT operations at a manufacturing plant, ensuring alignment with corporate standards and regulatory requirements.">Key Responsibilities:">">Oversee the implementation of information technology infrastructure to support production operations.">Provide GxP-compliant support for manufacturing systems (MES, LIMS, SCADA,...